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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K150826
Device Name Nutra Face Lift Model PE8050
Applicant
Nutra Luxe MD, LLC
6835 International Center Blvd. Unit 4-5
Fort Myers,  FL  33912
Applicant Contact PETER VON BERG
Correspondent
Nutra Luxe MD, LLC
12801 Commonwealth Dr. Units 2-6
Fort Myers,  FL  33913
Correspondent Contact Gloria Avendano
Regulation Number882.5890
Classification Product Code
NFO  
Date Received03/30/2015
Decision Date 02/10/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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